Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007023, 20F, Sterile.
FDA device recall Z-2188-2009 · posted 2009-09-15 · Terminated
Recall details
- Recalling firm
- C.R. Bard Access Systems, Inc
- Reason for recall
- The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.
- Action taken
- Bard contacted all 1,883 worldwide customers who received the distributed suspect 467 product code lots, comprising 177, 614 units that were either not expired or were still available in the field. These will be returned by the customer to Bard Access Systems. 1-800-290-1689.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 177,614 units
- Distribution
- Worldwide, including USA, Belgium, Canada, Australia, and Japan.
- Date initiated
- 2008-12-04
- Date posted
- 2009-09-15
- Date terminated
- 2011-11-09
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENTAKE STANDARD AND SAFETY PEG SYSTEM (K061021) | Conmedcorp | 2006-04-28 |
| FASTRAC GASTRIC ACCESS PORT KIT (K033562) | C.R. Bard, Inc. | 2003-12-12 |
| RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT (K972025) | Radius Intl., Inc. | 1998-01-23 |
| SOLITAIRE (K972101) | Heraeus Kulzer, Inc. | 1997-09-29 |
| BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC (K915841) | C.R. Bard, Inc. | 1993-06-25 |